US10881317B2 - Post-hoc atrial fibrillation detection - Google Patents

Post-hoc atrial fibrillation detection Download PDF

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US10881317B2
US10881317B2 US15/901,336 US201815901336A US10881317B2 US 10881317 B2 US10881317 B2 US 10881317B2 US 201815901336 A US201815901336 A US 201815901336A US 10881317 B2 US10881317 B2 US 10881317B2
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episode
arrhythmia
detection
cardiac signal
detected
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US20180256053A1 (en
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David L. Perschbacher
Sunipa Saha
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Cardiac Pacemakers Inc
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Cardiac Pacemakers Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
    • A61N1/3962—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy
    • A61B5/046—
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/361—Detecting fibrillation
    • A61B5/04012—
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/025—Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
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    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36507—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by gradient or slope of the heart potential
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/395—Heart defibrillators for treating atrial fibrillation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3987—Heart defibrillators characterised by the timing or triggering of the shock

Definitions

  • Ambulatory medical devices include implantable medical devices (IMDs), wearable medical devices, handheld medical devices, and other medical devices.
  • IMDs include cardiac function management (CFM) devices such as implantable pacemakers, implantable cardioverter defibrillators (ICDs), subcutaneous implantable cardioverter defibrillators (S-ICDs), cardiac resynchronization therapy devices (CRTs), and devices that include a combination of such capabilities.
  • CFM cardiac function management
  • ICDs implantable cardioverter defibrillators
  • S-ICDs subcutaneous implantable cardioverter defibrillators
  • CRTs cardiac resynchronization therapy devices
  • the devices can be used to treat patients or subjects using electrical or other therapy, or to aid a physician or caregiver in patient diagnosis through internal monitoring of a patient's condition.
  • Some implantable medical devices can be diagnostic-only devices, such as implantable loop recorders (ILRs), implantable cardiac monitors, and subcutaneously implantable heart failure monitors (SubQ HFMs).
  • the devices may include electrodes in communication with one or more sense amplifiers to monitor electrical heart activity within a patient, or can include one or more sensors to monitor one or more other patient parameters.
  • Subcutaneously implantable devices may include electrodes that are able to sense cardiac signals without being in direct contact with the patient's heart.
  • Other examples of IMDs include implantable drug delivery systems or implantable devices with neural stimulation capability (e.g., vagus nerve stimulator, baroreflex stimulator, carotid sinus stimulator, spinal cord stimulator, deep brain stimulator, etc.).
  • wearable medical devices include wearable cardioverter defibrillators (WCDs) and wearable diagnostic devices (e.g., an ambulatory monitoring vest, holter monitor, cardiac event monitor, or mobile cardiac telemetry devices).
  • WCDs can be monitoring devices that include surface electrodes.
  • the surface electrodes may be arranged to provide one or both of monitoring to provide surface electrocardiograms (ECGs) and delivery of cardioverter and defibrillator shock therapy.
  • ECGs surface electrocardiograms
  • a wearable medical device can also include a monitoring patch worn by the patient such as an adherable patch or can be included with an article of clothing worn by the patient.
  • handheld medical devices include smartphones and personal data assistants (PDAs).
  • the handheld devices can be diagnostic devices that record an electrocardiograph (ECG) or other physiological parameter while the device is resting in the patient's hand or being held to the patient's chest.
  • ECG electrocardiograph
  • CFM devices can be implantable but in some situations may not include dedicated atrial sensing capability. Additionally, some diagnostic-only implantable, wearable, and handheld devices do not include dedicated atrial sensing capability. Patients with these types of devices may develop atrial arrhythmias, such as atrial fibrillation (AF) for example. This may be especially true for heart failure patients who typically have a high incidence of AF. Knowledge that a specific patient is experiencing AF and the amount time the patient spend in AF can be useful to physicians and clinicians for diagnostic purposes or to tailor a treatment for the patient.
  • AF atrial fibrillation
  • the present subject matter relates to improving the detection or classification of atrial fibrillation and recording the fibrillation episode.
  • Example 1 can include subject matter (such as an apparatus) comprising an arrhythmia detection circuit.
  • the arrhythmia detection circuit is configured to: detect an episode of cardiac arrhythmia in the sensed cardiac signal using one or more first arrhythmia detection criteria and begin timing the duration of the arrhythmia episode; apply different arrhythmia detection criteria to a duration of the sensed cardiac signal prior to the detected episode of arrhythmia when the episode of arrhythmia is detected.
  • Example 2 the subject matter of Example 1 optionally includes a sensing circuit configured to generate a sensed cardiac signal representative of cardiac activity of a subject and operatively coupled to the arrhythmia detection circuit.
  • the arrhythmia detection circuit is configured to add the duration of the prior sensed cardiac signal to the time duration of the arrhythmia episode when arrhythmia is detected in the prior sensed cardiac signal using the different AF detection criteria; and generate a value of total time duration of the detected arrhythmia episode.
  • Example 3 the subject matter of one or both of Examples 1 and 2 optionally includes an arrhythmia detection circuit configured to: detect an episode of atrial fibrillation (AF) in the sensed cardiac signal using one or more first AF detection criteria and begin timing the duration of the AF episode; apply different AF detection criteria to a duration of the sensed cardiac signal prior to the detected episode of AF when the episode of AF is detected; add the duration of the prior sensed cardiac signal to the time duration of the AF episode when AF is detected in the prior sensed cardiac signal using the different AF detection criteria; and generate a value of total time duration of the detected AF episode.
  • AF atrial fibrillation
  • Example 4 the subject matter of one or any combination of Examples 1-3 optionally includes an arrhythmia detection circuit is configured to detect the episode of AF from the sensed cardiac signal using a plurality of AF detection criteria having first specificity and first sensitivity to AF detection, and apply a subset of the first AF detection criteria to a segment of the cardiac signal sensed prior to the detected episode of AF with at least one of different specificity or different sensitivity than the first AF detection criterion.
  • Example 5 the subject matter of one or any combination of Examples 1-4 optionally includes an arrhythmia detection circuit configured to detect the episode of AF when sensed ventricular depolarization intervals (V-V intervals) satisfy one or more of a specified V-V interval dispersion threshold, a specified V-V interval double decrement threshold, and a specified Wenkebach AF detection threshold, and classify a segment of the cardiac signal sensed prior to the detected episode as AF when using a change in one or more of the specified V-V interval dispersion threshold, the specified V-V interval double decrement threshold, and the specified Wenkebach AF detection threshold.
  • V-V intervals sensed ventricular depolarization intervals
  • Example 6 the subject matter of one or any combination of Examples 1-5 optionally includes an arrhythmia detection circuit configured to detect the episode of AF when noise in the sensed cardiac signal is less than a specified noise detection threshold, and classify the segment of the cardiac signal sensed prior to the detected episode as AF when noise in the segment satisfies a different noise detection threshold.
  • an arrhythmia detection circuit configured to detect the episode of AF when noise in the sensed cardiac signal is less than a specified noise detection threshold, and classify the segment of the cardiac signal sensed prior to the detected episode as AF when noise in the segment satisfies a different noise detection threshold.
  • Example 7 the subject matter of one or any combination of Examples 1-6 optionally includes an arrhythmia detection circuit configured to apply the first AF detection to the sensed cardiac signal according to sensing windows and count a number of the sensing windows in which AF is detected as the time duration of the AF episode, and add a sensing window prior to a first sensing window in which AF is detected to the count of the number of sensing windows when AF is detected in the prior sensing window using the different AF detection criteria.
  • an arrhythmia detection circuit configured to apply the first AF detection to the sensed cardiac signal according to sensing windows and count a number of the sensing windows in which AF is detected as the time duration of the AF episode, and add a sensing window prior to a first sensing window in which AF is detected to the count of the number of sensing windows when AF is detected in the prior sensing window using the different AF detection criteria.
  • Example 8 the subject matter of one or any combination of Examples 1-7 optionally includes a control circuit configured to trigger storage of sampled values of a segment of the sensed cardiac signal that includes the detected episode of AF when the episode of AF is detected using the first AF detection criteria, and trigger storage of sampled values of a segment of the cardiac signal that includes both the detected episode of AF and the sensed cardiac signal prior to the detected episode of AF when AF is detected in the prior sensed cardiac signal.
  • a control circuit configured to trigger storage of sampled values of a segment of the sensed cardiac signal that includes the detected episode of AF when the episode of AF is detected using the first AF detection criteria, and trigger storage of sampled values of a segment of the cardiac signal that includes both the detected episode of AF and the sensed cardiac signal prior to the detected episode of AF when AF is detected in the prior sensed cardiac signal.
  • Example 9 the subject matter of one or any combination of Examples 1-8 optionally includes an arrhythmia detection circuit is configured to accumulate a plurality of detected episodes of AF into a total time of AF burden for the subject and generate an alert according to the total time of AF burden.
  • Example 10 the subject matter of one or any combination of Examples 1-9 optionally includes a therapy circuit configured to provide electrical pacing therapy to the subject; and a control circuit configured to initiate delivery of the electrical pacing therapy according to a first pacing therapy mode, and change the pacing therapy mode according to the value of total time duration of the detected AF episode.
  • Example 11 the subject matter of one or any combination of Examples 1-10 optionally includes a therapy circuit configured to provide defibrillation shock therapy to the subject; and a control circuit configured to initiate delivery of the defibrillation shock therapy when the total time duration of the detected AF episode exceeds a specified time duration threshold.
  • Example 12 the subject matter of one or any combination of Examples 1-11 optionally includes an arrhythmia detection circuit configured to generate an indication of the start time of the episode of arrhythmia when the episode of arrhythmia is detected in the prior sensed cardiac signal.
  • an arrhythmia detection circuit configured to generate an indication of the start time of the episode of arrhythmia when the episode of arrhythmia is detected in the prior sensed cardiac signal.
  • Example 13 includes subject matter (such as a method of operating an ambulatory medical device, a means for performing acts, or a machine-readable medium including instructions that, when performed by the machine, cause the machine to perform acts), or can optionally be combined with one or any combination of Examples 1-12 to include such subject matter, comprising sensing a cardiac signal representative of cardiac activity of a subject; detecting an episode of cardiac arrhythmia in the sensed cardiac signal using one or more first arrhythmia detection criteria and timing the duration of the arrhythmia episode; applying, when the episode of arrhythmia is detected, different one or more arrhythmia detection criteria to a duration of the sensed cardiac signal prior to the detected episode of arrhythmia; adding the duration of the prior sensed cardiac signal to the time duration of the arrhythmia episode when arrhythmia is detected in the prior sensed cardiac signal using the different arrhythmia detection criteria; and providing the total time duration of the detected arrhythmia episode to a user or process.
  • subject matter such as a method of operating an ambulatory medical
  • Example 14 the subject matter of Example 13 optionally includes detecting an episode of atrial fibrillation (AF) in the sensed cardiac signal using one or more first AF detection criteria and timing the duration of the AF episode, wherein the applying the different arrhythmia detection criteria includes applying different one or more AF detection criteria to a duration of the sensed cardiac signal prior to the detected episode of AF when the episode of AF is detected.
  • AF atrial fibrillation
  • Example 15 the subject matter of Example 14 optionally includes the one or more first AF detection criteria including a plurality of AF detection criteria having first specificity and first sensitivity to detection of AF, and wherein the different one or more AF detection criteria includes a subset of the first AF detection criteria with at least one of different specificity or different sensitivity than the first AF detection criterion.
  • Example 16 the subject matter of one or both of Examples 14 and 15 optionally includes the one or more first AF detection criteria including detecting when sensed ventricular depolarization intervals (V-V intervals) satisfy one or more of a specified V-V interval dispersion threshold, a specified V-V interval double decrement threshold, and a specified Wenkebach AF detection threshold, and wherein the different one or more AF detection criteria includes a change in one or more of the specified V-V interval dispersion threshold, the specified V-V interval double decrement threshold, and the specified Wenkebach AF detection threshold.
  • V-V intervals sensed ventricular depolarization intervals
  • Example 17 the subject matter of one or any combination of Examples 13-16 optionally includes the one or more first AF detection criteria including detecting when noise in the sensed cardiac signal is less than a specified noise detection threshold, and wherein the different one or more AF detection criteria includes detecting when noise in the sensed cardia signal is less than a different specified noise detection threshold.
  • Example 18 the subject matter of one or any combination of Examples 13-17 optionally includes detecting the episode of AF during a first sensing window, wherein the timing the duration of the AF window includes counting a number of sensing windows with the AF episode, and wherein the adding the duration of the prior sensed cardiac signal to the AF episode includes adding a sensing window prior to the first sensing window to the count of the number of sensing windows with the AF episode.
  • Example 19 includes subject matter (such as a system), or can optionally be combined with one or any combination of Examples 1-18 to include such subject matter, comprising: an implantable cardiac lead including one or more implantable electrodes; a cardiac signal sensing circuit operatively coupled to the electrodes and configured to provide a sensed ventricular cardiac signal of a subject; and an arrhythmia detection circuit operatively coupled to the cardiac signal sensing circuit and configured to: detect an episode of atrial fibrillation (AF) in the sensed ventricular cardiac signal in absence of dedicated atrial chamber sensing using one or more first AF detection criteria, and begin timing the duration of the AF episode; apply different AF detection criteria to a duration of the sensed cardiac signal prior to the detected episode of AF when the episode of AF is detected; add the duration of the prior sensed cardiac signal to the time duration of the AF episode when AF is detected in the prior sensed cardiac signal using the different AF detection criteria; and generate a value of total time duration of the detected AF episode.
  • AF atrial fibrillation
  • Example 20 the subject matter of Example 19 optionally includes an arrhythmia detection circuit configured to detect the episode of AF using a plurality of AF detection criteria to the sensed cardiac signal having first specificity and first sensitivity to AF detection, and apply a subset of the first AF detection criteria to a segment of the cardiac signal sensed prior to the detected episode of AF with at least one of different specificity or different sensitivity than the first AF detection criterion.
  • an arrhythmia detection circuit configured to detect the episode of AF using a plurality of AF detection criteria to the sensed cardiac signal having first specificity and first sensitivity to AF detection, and apply a subset of the first AF detection criteria to a segment of the cardiac signal sensed prior to the detected episode of AF with at least one of different specificity or different sensitivity than the first AF detection criterion.
  • Example 21 the subject matter of one or both of Examples 19 and 20 optionally includes an arrhythmia detection circuit configured to detect the episode of AF when sensed ventricular depolarization intervals (V-V intervals) satisfy one or more of a specified V-V interval dispersion threshold, a specified V-V interval double decrement threshold, and a specified Wenkebach AF detection threshold, and classify a segment of the cardiac signal sensed prior to the detected episode as AF when using a change in one or more of the specified V-V interval dispersion threshold, the specified V-V interval double decrement threshold, and the specified Wenkebach AF detection threshold.
  • V-V intervals sensed ventricular depolarization intervals
  • Example 22 the subject matter of Example 21 optionally includes an arrhythmia detection circuit configured to detect the episode of AF when noise in the sensed cardiac signal is less than a specified noise detection threshold, and classify the segment of the cardiac signal sensed prior to the detected episode as AF when noise in the segment satisfies a different noise detection threshold.
  • an arrhythmia detection circuit configured to detect the episode of AF when noise in the sensed cardiac signal is less than a specified noise detection threshold, and classify the segment of the cardiac signal sensed prior to the detected episode as AF when noise in the segment satisfies a different noise detection threshold.
  • Example 23 can include, or can optionally be combined with any portion or combination of any portions of any one or more of Examples 1-22 to include, subject matter that can include means for performing any one or more of the functions of Examples 1-22, or a machine-readable medium including instructions that, when performed by a machine, cause the machine to perform any one or more of the functions of Examples 1-22.
  • FIG. 1 is an illustration of an example of portions of a medical device system that includes an IMD.
  • FIGS. 2 and 3 are illustrations of further examples of an IMD.
  • FIG. 5 is a flow diagram of an example of a method of operating an ambulatory medical device.
  • FIG. 7 shows a representation of a sensed cardiac signal.
  • FIG. 9 shows a graph of an example of a heart rate distribution for normal sinus rhythm.
  • FIG. 11 is an illustration of an example of arrhythmia detection windows.
  • FIG. 12 is a flow diagram of another example of a method of operating an ambulatory medical device.
  • An ambulatory medical device can include one or more of the features, structures, methods, or combinations thereof described herein.
  • a cardiac monitor or a cardiac stimulator may be implemented to include one or more of the advantageous features or processes described below. It is intended that such a monitor, stimulator, or other ambulatory device need not include all of the features described herein, but may be implemented to include selected features that provide for unique structures or functionality. Such a device may be implemented to provide a variety of therapeutic or diagnostic functions.
  • FIG. 1 is an illustration of an example of portions of a system 100 that includes an ambulatory medical device that is an IMD 105 .
  • the IMD 105 include, without limitation, a pacemaker, a cardioverter, a defibrillator, and other cardiac monitoring and therapy delivery devices, including cardiac devices that include or work in coordination with one or more neuro-stimulating devices, drugs, drug delivery systems, or other therapies.
  • the system 100 shown is used to treat cardiac arrhythmias.
  • the IMD 105 typically includes an electronics unit coupled by one or more cardiac leads 115 to a heart of a patient or subject.
  • the electronics unit of the IMD 105 typically includes components that are enclosed in a hermetically-sealed housing sometimes referred to as a canister or “can.”
  • the system 100 also typically includes an IMD programmer or other external system 190 that communicates one or more wireless signals 185 with the IMD 105 , such as by using radio frequency (RF) or by one or more other telemetry methods.
  • RF radio frequency
  • the example shown includes a right ventricular (RV) lead 115 having a proximal end and a distal end.
  • the proximal end is coupled to a header connector 107 .
  • the distal end is configured for placement in the RV.
  • the RV lead 115 can include one or more of a proximal defibrillation electrode 116 , a distal defibrillation electrode 118 (e.g., RV Coil), an RV tip electrode 120 A, and an RV ring electrode 120 B.
  • the defibrillation electrode 116 is generally incorporated into the lead body such as in a location suitable for supraventricular placement in the superior vena cava (e.g., SVC Coil).
  • the RV lead 115 includes a ring electrode 132 (e.g., SVC ring) in the vicinity of the proximal defibrillation electrode 116 .
  • the defibrillation electrode 118 is incorporated into the lead body near the distal end, such as for placement in the RV.
  • the RV electrodes 120 A and 120 B can form a bipolar electrode pair and are generally incorporated into the lead body at the lead distal end.
  • the electrodes 116 , 118 , 120 A, and 120 B are each electrically coupled to IMD 105 , such as through one or more conductors extending within the lead body.
  • the proximal defibrillation electrode 116 , distal defibrillation electrode 118 , or an electrode formed on the can of IMD 105 allow for delivery of cardioversion or defibrillation pulses to the heart.
  • the RV tip electrode 120 A, RV ring electrode 120 B, or an electrode formed on the can of IMD 105 allow for sensing an RV electrogram signal representative of RV depolarizations and delivering RV pacing pulses.
  • the 1 MB 105 includes a sense amplifier circuit to provide amplification or filtering of the sensed signal. Sensing and pacing allows the 1 MB 105 to adjust timing of the heart chamber contractions.
  • the 1 MB 105 can be an ICD with single ventricular chamber sensing.
  • the ICD can include an electrode attached to a single ventricular lead, and use intrinsic cardiac signals sensed with the ventricular electrode for arrhythmia detection and discrimination (e.g., by rate sensing and/or depolarization signal morphology analysis).
  • An IMD may be a diagnostic-only device that does not provide electrical therapy to the patient. Note that the specific arrangement of leads and electrodes are shown the illustrated example of FIG. 1 is intended to be non-limiting.
  • FIG. 2 is an illustration of another example of portions of a system 200 that includes an S-ICD 205 .
  • the S-ICD 205 is implantable subcutaneously and includes a lead 215 .
  • the lead 215 is implanted subcutaneously and the proximal end of the lead 215 is coupled to a header connector 207 .
  • the lead 215 can include electrode 220 A and electrode 220 B to sense ventricular depolarization (e.g., using far-field sensing), but in the example illustrated, the lead does not include any electrodes that directly contact the heart.
  • the lead 215 includes a defibrillation electrode 218 that may be a coil electrode.
  • the S-ICD 205 may provide one or more of cardioversion therapy and defibrillation high energy shock therapy to the heart using the defibrillation electrode 218 and an electrode formed on the can of the S-ICD 205 .
  • the S-ICD 205 may also provide pacing pulses for anti-tachycardia therapy or bradycardia therapy. Note that atrial leads are not provided in the arrangement of the electrodes, but electrodes 220 A and 220 B allow for sensing a far-field ventricular electrogram signal.
  • FIG. 3 is an illustration of an example of an IMD that is a leadless cardiac pacemaker 305 .
  • the leadless pacemaker 305 is shown positioned within a ventricular chamber, but the leadless pacemaker 305 may be positioned at other locations of the heart.
  • the leadless pacemaker 305 example has a cylindrical housing and may include one or more electrodes arranged along the cylindrical housing to sense electrical signals of the heart and/or provide electrical stimulation for pacing the heart. In some instances the one or more electrodes may be used for communication.
  • the leadless pacemaker 305 may include a mechanism 330 to secure the leadless pacemaker 305 to the heart. Examples of the fixation mechanism can include one or more tines, or one or more helix-shaped fixation mechanisms.
  • the electrodes may not be in direct contact with the atrium, but the electrodes may provide an RV electrogram signal.
  • an IMD include an implantable cardiac recorder (ICM).
  • the ICM may be a diagnostic device inserted subcutaneously to monitor the electrical signals and, depending on the device, other signals of the heart.
  • the ICM may include two or more electrodes on the housing and/or header of the device to sense the electrical signals of the heart. In some cases, no electrodes are provided in or on the heart.
  • FIG. 4 is an illustration of portions of another example of a medical device system 400 .
  • the system 400 may include one or more ambulatory medical devices, such as a conventionally implantable or subcutaneously implantable medical device 405 , a wearable medical device 410 , or a handheld medical device 403 , or any other medical device described herein.
  • One or more of the medical devices can include a communication circuit (e.g., a telemetry circuit) to communicate an indication of cardiac arrhythmia (e.g., AF) to a communication system 407 .
  • a communication circuit e.g., a telemetry circuit
  • the communication system 407 can include an external communication device 412 and a remote system 414 that communicates with the external communication device 412 via a network 418 (e.g., the internet, a proprietary computer network, or a cellular phone network).
  • the remote system 414 may include a server 416 remotely located from the external communication device 412 and the subject to perform further processing of the cardiac data or other patient management functions.
  • the external communication device 412 may include a programmer to program parameters of the implantable medical device.
  • One or both of the external communication device 412 and the remote system 414 may include a display to present the indication of arrhythmia to a user, such as a clinician.
  • FIG. 5 is a flow diagram of an example of a method 500 of controlling operation of an ambulatory medical device system to detect atrial arrhythmias.
  • a cardiac signal representative of cardiac activity of a subject is sensed by the device.
  • an episode of atrial arrhythmia e.g., AF
  • the medical device begins timing the duration of the detected arrhythmia episode.
  • the device analyzes a duration of the cardiac signal sensed prior to the detected episode of arrhythmia using a different arrhythmia detection criterion or criteria.
  • the different detection criteria for the arrhythmia may change one or both of the sensitivity and specificity of the arrhythmia detection from the first criteria.
  • Sensitivity refers to the ability of the detection scheme of a device to effectively detect an abnormal heart rhythm that the device may treat.
  • Specificity refers to the ability of the detection scheme of a device to correctly identify heart rhythm that the device is not intended to detect or treat (e.g., normal rhythms, other types of arrhythmias, or noise mistakenly identified as cardiac arrhythmia).
  • the sensitivity of the arrhythmia detection may be changed to be more inclusive of possible arrhythmia in the signal segment prior to the detected episode.
  • the prior signal segment may be sampled and stored in a memory buffer of the device (e.g., as an electrogram), and the second detection criteria is applied to the stored segment.
  • the ambulatory medical device adds the duration of the prior sensed cardiac signal to the time duration of the arrhythmia episode when arrhythmia is detected in the prior sensed cardiac signal using the different arrhythmia detection criteria. Accuracy of the device-determined total time of the arrhythmia episode can be improved by this “look-back” feature that checks whether episodes of arrhythmia were missed by the first detection criteria.
  • the device provides the duration of the detected arrhythmia episode to a user or process.
  • the ambulatory medical device detects AF in the sensed cardiac signal using first AF detection criteria and begins timing the AF episode. The device then applies different AF detection criteria to the duration of the sensed cardiac signal prior to the detected episode of AF. When AF is detected in the prior signal segment, the duration of the prior episode can be added to the total time of the AF episode. In this way, the device may detect missed episodes of AF that can be included in the total time of the AF episodes to improve determination of AF burden for the patient or subject.
  • the ambulatory medical device may store electrograms or ECGs of detected arrhythmia episodes.
  • the look-back feature allows for the prior signal segment to be included in the stored electrogram or ECG to be later uploaded from the device for analysis by a clinician if the arrhythmia is detected in the prior segment.
  • the look-back feature may prevent the additional information from being lost or ignored.
  • the additional information obtained can be reviewed by a clinician and used to adjust a treatment of the patient.
  • This adjusting can include adjusting drug titration, changing the drug used in the therapy, prescribing an implantable medical device for the patient, adjusting the therapy (e.g. electrostimulation therapy) of an implantable device prescribed to the patient, or ordering an ablation procedure for the patient.
  • therapy e.g. electrostimulation therapy
  • FIG. 6 is a block diagram of portions of an example of an ambulatory medical device.
  • the device 600 includes a sensing circuit 610 , a control circuit 615 , an arrhythmia detection circuit 620 , and may include a memory 625 .
  • the sensing circuit 610 may generate a sensed cardiac signal representative of cardiac activity of a subject.
  • the sensing circuit 610 may be electrically coupled to one or more implantable electrodes included in a lead arranged for placement in a heart chamber.
  • the sensing circuit 610 may be electrically coupled to one or more implantable electrodes included in a leadless implantable medical device.
  • the sensing circuit 610 may be electrically coupled to one or more implantable electrodes configured to sense cardiac signals without direct cardiac contact with the subject (e.g., a subcutaneously implantable electrode).
  • the sensing circuit 610 , the control circuit 615 , the arrhythmia detection circuit 620 , and the memory 625 are included in a wearable device or a handheld device.
  • the memory can be included in a separate device or can be a central memory located in a network “cloud.”
  • the control circuit 615 may include a microprocessor, a digital signal processor, application specific integrated circuit (ASIC), or other type of processor, interpreting or executing instructions included in software or firmware.
  • the memory 625 may be integral to or separate from the control circuit 615 .
  • the arrhythmia detection circuit 620 may also be integral to the control circuit 615 or may be separate from the control circuit 615 .
  • the sensing circuit 610 is included in a first device and the arrhythmia detection circuit and the control circuit are included in a second separate device.
  • the first device is implantable and the second devices is external.
  • the arrhythmia detection circuit 620 may detect an episode of cardiac arrhythmia in the sensed cardiac signal using one or more arrhythmia detection criteria. For instance, the arrhythmia detection circuit 620 may be configured to detect AF. In some examples, the arrhythmia detection circuit 620 uses ventricular depolarization (V-V) interval dispersion to detect AF.
  • V-V ventricular depolarization
  • FIG. 7 shows a representation of a sensed cardiac signal 705 .
  • the sensed signal is shown having a number of R-waves 710 .
  • the V-V intervals can be determined as intervals between R-waves.
  • RR 1 in the Figure refers to the first interval between the first two R-waves;
  • RR 2 is the second interval between the second R-wave and the third R-wave, and so on.
  • Differences between the V-V intervals are referred to ⁇ RR 1,2 (e.g., the difference between the RR 2 and RR 1 ), ⁇ RR 2,3 and so on.
  • FIG. 8 shows an example of a sensed physiological signal having a first region 805 corresponding to NSR and a second region 810 corresponding to AF.
  • the V-V intervals may be more regular and the differences in the V-V intervals will be small.
  • the V-V intervals may be more disperse and the values of the differences in the V-V intervals may be more varied than for NSR.
  • the arrhythmia detection circuit 620 may include a peak detector circuit to detect R-waves in the sensed physiological signal to determine V-V intervals.
  • the arrhythmia detection circuit 620 may sample the V-V intervals and store the samples in device memory 625 or a different memory.
  • the arrhythmia detection circuit 620 may determine differences between the V-V intervals and determine a measure of V-V interval dispersion using the determined V-V interval differences.
  • the arrhythmia detection circuit 620 determines the differences in the V-V intervals and may classify the interval differences as one of stable or unstable.
  • the interval difference classifications can be used to determine V-V interval dispersion.
  • An interval difference may be classified as stable when the interval difference is less than a specified threshold difference value from an immediately previous interval difference.
  • An interval difference may be classified as unstable when the interval difference is more than the specified threshold difference value from the immediately previous interval difference.
  • the threshold difference value is a value corresponding to less than a 10 bpm difference in rate between the two intervals.
  • the arrhythmia detection circuit 620 detects AF when sensed V-V intervals satisfy a specified V-V interval double decrement threshold.
  • An interval double decrement occurs when two consecutive V-V intervals occur in which heart rate decreases in both intervals.
  • RR 1 is 857 ms corresponding to 70 bpm and RR 2 is 1000 ms corresponding to 60 bpm
  • a double decrement occurs if the next interval RR 3 is greater than 1000 ms (e.g., 1090 ms corresponding to the 55 bpm). If RR 3 is less than 1000 ms, heart rate did not decrease in two consecutive V-V intervals and a double decrement did not occur.
  • the arrhythmia detection circuit may detect AF when the number of double decrement intervals exceeds a specified fraction or percentage of the intervals.
  • Premature atrial contractions can cause false positives in AF detection schemes.
  • Including the double decrement detection criterion in an AF detection scheme can reduce false positives.
  • the threshold fraction or percentage can be lowered to make the detection more sensitive or raised to make the detection more specific for AF detection.
  • the arrhythmia detection circuit 620 detects AF when sensed V-V intervals satisfy a specified V-V interval Wenkebach threshold.
  • Wenkebach detection involves an analysis of how truly irregular is an arrhythmia that first appears to be irregular, but may actually include some regularity or pattern.
  • the arrhythmia detection circuit 620 may detect AF when the measured Wenkebach regularity of the rhythm is less than a specified Wenkebach threshold. For instance, measuring the regularity may include determining one or both of similar maximum heart rate and similar minimum heart rate.
  • the arrhythmia detection circuit 620 may look for a consecutive number of X-beat windows in the sensed cardiac signal, where X is a positive integer greater than one (e.g., 2, 3 . . . or 7 beat windows). Multiple different window sizes are applied to the sensed cardiac signal.
  • the arrhythmia detection circuit 620 determines the highest percentage of X-beat windows with similar maximum heart rates (and/or similar minimum heart rates).
  • a “similar” maximum or minim heart rate means that the max (or min) for a given window is within, as an example, +/ ⁇ 5 bpm of the previous window max (or min).
  • the arrhythmia detection circuit 620 does not detect AF. If the fraction or percentage of maximum heart rate (and/or minimum heart rate) of all of the window sizes are less than the specified Wenkebach threshold, the arrhythmia detection circuit 620 detects AF. In the example of Table I, 20% of the consecutive 2-beat windows had a similar maximum heart rate and 25% had a similar minimum heart rate, and 75% of the consecutive 7-beat windows had similar maximum heart rates and 80% had similar minimum heart rates. If the Wenkebach threshold percentage is specified as 40%, the arrhythmia detection circuit 620 would not detect AF in the example.
  • window sizes 4 through 7 would negate a finding of AF because a repeating pattern is found for those window sizes that meets the Wenkebach detection criterion.
  • the threshold fraction or percentage can be raised to make the detection more sensitive or lowered to make the detection more specific for AF detection.
  • the arrhythmia detection circuit 620 may detect AF when the determined score satisfies a specified AF detection threshold.
  • the detection for AF can be adjusted to be more sensitive or less sensitive by adjusting the threshold score.
  • FIG. 10 shows a graph of an example of a heart rate distribution for a patient in AF. It can be seen that heart rate is less regular in AF than in NSR. In the example of FIG. 10 , the HRDI is approximately 23%. AF can be detected when the HRDI is less than a specified detection threshold fraction or percentage. The detection for AF can be adjusted to be more sensitive or less sensitive by adjusting the detection threshold.
  • the control circuit 615 may begin timing the duration of the arrhythmia episode.
  • a determination of the total time that the subject is in AF (the AF burden) can be impacted when AF detection thresholds are applied to an atrial rhythm that is fluctuating around the AF detection thresholds.
  • the medical device may be configured to detect AF using one or more criteria that may miss arrhythmias that belong to the AF episode.
  • all of the detection thresholds can be made more sensitive to detect more AF, or can be made more specific to be more discriminatory in what is classified as AF.
  • the look-back criteria is determined using the normal sinus rhythm (NSR) of the subject as a baseline.
  • NSR normal sinus rhythm
  • the arrhythmia detection circuit 620 sets the threshold in the look-back detection criteria to be between the value used in the initial AF detection and the value when the subject is in NSR.
  • the cardiac signal sensing circuit may not include dedicated sensing circuits for the atrial chambers of the subject.
  • the AF detection is applied to a cardiac signal sensed by a ventricular sensing circuit or circuits.
  • the device-based AF detection methods of measuring V-V interval dispersion, detection of V-V interval double-decrements, measuring V-V interval Wenkebach regularity, measuring HRDI, and performing morphology analysis can be implemented with only ventricular sensing. In this way, AF can be detected without including dedicated atrial sensing in the ambulatory medical device. If atrial sensing circuits are available, other criterion can be used for the AF detection.
  • the AF window count is incremented to include the non-AF window, and the process continues applying the first AF detection criteria to new windows at 1220 . If the AF window is noisy, the process continues at 1220 and the first AF detection criteria continues to be applied to new windows. If AF continues to be detected, the AF window count is incremented at 1225 . If AF is no longer detected, the process returns to looking for AF at 1205 .
  • the AF window count can be used to determine the duration of the AF episode. Multiple detected AF episodes can be accumulated into a total time of AF burden for the subject.
  • the stored signal segment can be transferred to the event storage buffer.
  • the memory portion storing the cardiac signal segment is re-designated as non-temporary storage and the contents are not transferred.
  • the event storage buffer then includes both the detected episode of AF and the sensed cardiac signal prior to the detected episode of AF.
  • the stored cardiac signal includes the AF onset or start of the AF episode, which may otherwise be lost. Because the actual AF onset may occur during the look back window, the look-back feature can improve accuracy in reporting of the time of the onset of AF.
  • the arrhythmia detection circuit may generate an indication of the start time of the episode of arrhythmia when the episode of arrhythmia is detected in the prior sensed cardiac signal. The indication may be the time of the onset stored in a memory location that can be later uploaded, or the indication of the start time can be included in a report that lists different parameters of the AF episode such as start time and the duration of the episode.
  • the system or device does not require direct atrial activity sensing for atrial arrhythmias detection, the system complexity and implementation cost may be reduced. It may particularly be beneficial for patient not indicated for atrial lead implantation either for atrial activity sensing or for atrial pacing.
  • the device-based arrhythmia detection also allows for more efficient use of device memory, such as by correctly storing heart rate statistics that are clinically relevant to arrhythmia recognition. Because onset of AF is more accurately reported, fewer unnecessary drugs and procedures can be scheduled, prescribed, or provided, and the overall management of the patient's cardiac disease can be improved.
  • the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.”
  • the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated.
  • Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples.
  • An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code can form portions of computer program products. Further, the code can be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times.
  • a carrier medium can carry code implementing the methods.
  • carrier medium can be used to represent carrier waves on which code is transmitted.

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